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Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) is at the forefront of RNA interference (RNAi) therapeutics, pioneering a transformative class of medicines aimed at treating and potentially curing a wide range of diseases. Founded in 2002 and based in Cambridge, MA, Alnylam has translated Nobel Prize-winning science into five commercial products: ONPATTRO (patisiran), AMVUTTRA (vutrisiran), GIVLAARI (givosiran), OXLUMO (lumasiran), and Leqvio (inclisiran), developed and commercialized in partnership with Novartis. These breakthrough therapeutics address conditions such as hATTR amyloidosis, acute hepatic porphyria, primary hyperoxaluria type 1, and hypercholesterolemia.
Alnylam is dedicated to expanding its pipeline with several investigational medicines in late-stage development, focusing on genetic medicines, cardio-metabolic diseases, hepatic infectious diseases, and CNS/ocular diseases. The company’s commitment to sustainable innovation is reflected in its robust product pipeline and strategic collaborations with industry leaders like Roche and Regeneron.
Financially, Alnylam reported robust growth in 2023 with $1.24 billion in global net product revenues, a reflection of its strong commercial execution across its therapeutic products. The company maintains a strong cash position, bolstered by upfront fees from research partnerships and milestone achievements.
Alnylam is also dedicated to corporate responsibility, with initiatives aimed at reducing greenhouse gas emissions, promoting diversity and inclusion in clinical trials, and expanding global health equity through its Alnylam Challengers program. The company’s environmental impact data is third-party verified, underscoring its commitment to transparency and sustainability.
Looking ahead, Alnylam aims to sustain its leadership in RNAi therapeutics with the anticipated release of topline results from the HELIOS-B Phase 3 study and the continued development of promising candidates like zilebesiran for hypertension and mivelsiran for Alzheimer’s disease. For more details on Alnylam’s people, science, and pipeline, visit www.alnylam.com.
Alnylam Pharmaceuticals announced positive results from the APOLLO-B Phase 3 study of patisiran, an investigational RNAi therapeutic for treating ATTR amyloidosis with cardiomyopathy. The study met its primary endpoint, showing a significant improvement in functional capacity (14.7 meters in 6-MWT) and health status (3.7 points in KCCQ-OS) compared to placebo after 12 months. Safety profiles were encouraging, with no major cardiac concerns. A supplemental new drug application is planned, indicating a potential market opportunity for patisiran if approved.
Alnylam Pharmaceuticals (NASDAQ: ALNY) will present a company overview at the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, at 11:10 am ET. The event will take place at the Sheraton New York Hotel. Investors can access a live audio webcast on the company’s website, with a replay available within 48 hours post-event. Alnylam is known for pioneering RNA interference (RNAi) therapeutics, addressing rare diseases with innovative products like ONPATTRO and GIVLAARI.
Alnylam Pharmaceuticals announced positive results from a Phase 2 study of cemdisiran for treating immunoglobulin A nephropathy (IgAN). The study demonstrated a 37% reduction in the 24-hour urine protein to creatinine ratio compared to placebo. Notably, 32% of patients on cemdisiran achieved a significant reduction in protein levels, compared to 13% on placebo. The treatment was well tolerated, with common side effects being injection site reactions. Alnylam aims to advance cemdisiran to Phase 3 development, addressing the significant unmet needs in IgAN treatment.
Alnylam Pharmaceuticals has appointed Dr. Elliott Sigal to its Board of Directors, enhancing its leadership at a pivotal moment. With decades of experience, including his role as Chief Scientific Officer at Bristol-Myers Squibb, Dr. Sigal contributed to the launch of 14 new medicines across various therapeutic areas. His expertise is expected to strengthen Alnylam's ongoing efforts in advancing RNAi therapeutics aimed at rare diseases. The company continues its pursuit of transforming healthcare through innovative treatments, guided by its 'Alnylam P5x25' strategy.
Alnylam Pharmaceuticals has announced the presentation of data from the APOLLO-B Phase 3 study of patisiran at the 18th International Symposium on Amyloidosis on
Alnylam Pharmaceuticals announced that the APOLLO-B Phase 3 study of patisiran met its primary endpoint, showing a statistically significant improvement in the 6-Minute Walk Test compared to placebo at 12 months (p-value 0.0162). The study also achieved its first secondary endpoint, indicating improved quality of life via the Kansas City Cardiomyopathy Questionnaire (p-value 0.0397). The company plans to file a Supplemental New Drug Application in the U.S. in late 2022. Patisiran demonstrated a favorable safety profile, with fewer deaths in the treatment arm.
Alnylam Pharmaceuticals reported Q2 2022 net product revenues of $214 million, a 33% increase year-over-year, driven by strong performance from ONPATTRO and GIVLAARI. The company received FDA approval for AMVUTTRA, marking its fifth RNAi therapeutic. Alnylam expects topline results from the APOLLO-B Phase 3 trial of patisiran within three weeks and reiterated its 2022 financial guidance of combined net product revenues between $870 million and $930 million.
Alnylam Pharmaceuticals has published research in Nature Communications indicating that individuals with mutations in the INHBE gene exhibit reduced abdominal fat, a favorable metabolic profile, and lower risks for cardiovascular disease and type 2 diabetes. The study, which analyzed data from over 360,000 people, suggests that targeting INHBE may provide new therapeutic options for cardiometabolic diseases. Alnylam aims to develop a candidate targeting INHBE using its IKARIA™ platform.
This breakthrough highlights the potential to address obesity and its associated health risks effectively.
Alnylam Pharmaceuticals (NASDAQ: ALNY) announced a positive opinion from the European Medicines Agency's CHMP for its RNAi therapeutic, vutrisiran, aimed at treating hATTR amyloidosis in adult patients. The European Commission's decision is expected in September 2022. Vutrisiran is notable for being the first treatment to show reversal in neuropathy impairment with quarterly subcutaneous administration. This therapy met all study endpoints in the HELIOS-A Phase 3 trial, demonstrating safety and efficacy. Vutrisiran is already approved in the U.S. and is under review in Brazil and Japan.
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